Hospitalized children undergo an average of approximately 7 painful procedures a day in Canada, often requiring pharmacological intervention to reduce pain and anxiety. Several potential anxiolytic agents are available, differing in adverse event profile, duration and degree of pain and distress reduction, and route of administration (intravenous, oral, intramuscular, intranasal). This variation has contributed to a lack of consensus on the optimal agent among clinicians and a request for more clinical research in this area.

A direct comparison of all paediatric anxiolytic options requires an unfeasibly large sample size and has inherent difficulties comparing treatments with diverse profiles. This project is building on the current clinical evidence to design a viable research program that will reduce clinical uncertainty in a cost-effective and timely manner. We will use Value of Information (VoI) methods to target research towards gaps in the current body of evidence that restrict clinicians’ ability to select the optimal anxiolytic. This project is: 

  1. Synthesizing information from published research on clinical outcomes (i.e. pain and distress reduction, adverse effects) and costs for the different therapeutic interventions to understand how clinical choices for anxiolytics are made.
  2. Employing VoI methods to assess what, if any, additional research should be carried out to guide clinical decision-making.
  3. Undertaking a pilot study to assess the feasibility of our proposed research strategy. 

To date, VoI methods have been chiefly presented in theoretical terms and have not been translated effectively in to clinical research. A key reason for this is the difference between determining statistical significance, usually required in clinical research, and supporting decision making using decision analysis. Thus, this project is working with an interdisciplinary team across Canada to overcome this hurdle and successfully translate VoI into clinical research, improving efficiency and reduce costs of research across diverse disease areas. This project will also inform a key clinical question; what is the optimal anxiolytic agent and route for use in children?